Design Quality Engineer

Design Quality Engineer at Onsite (Zurich, Switzerland)

Design Quality Engineer:

• Sound Engineer knowledge and experience in Medical devices

• Strong Knowledge in verification and validation summary documents.

• Experience in engineering memos and engineering rationale.

• Experience in Product transfer projects.

• Strong Knowledge in DCRM, sales & complaint data, risk management reports and any other technical documents related to design and manufacturing.

• Mentoring skills to guide the PD team on all design control documentation to ensure that the documentation is in accordance with the current design quality guidelines

• Strong Knowledge in regulatory documents including essential requirement checklist, standard evaluation documents etc.

• Experience in design change evaluation checklists for all labeling documents (eg: surgical technique guide, IFU, patient care guide..)

• Strong communication skills to Communicate at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing.

• Strong Knowledge in all other standard Design Quality related day to day activities related to design transfer and manufacturing processes.

• German proficiency will be added advantages.

Qualifications

• Education and Experience:

• Essential:

• Degree Qualified ( Preferred biomedical or Mechanical ) with 5+ years relevant experience in Medical Devices Industry

• Ability to work on own initiative

• Flexible work ethic

• Excellent working knowledge of process excellence / QE tools such as pFMEA , SE , statistical analysis , SPC

• CAPA and RCI experience

• Excellent IT skill eg , experience in minitab , excel reports

• Job type: Contract Division: eTeam Workforce Limited - Netherland Reference: 24-01261